http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Mon, 24 Aug 2026 08:30:52 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html <p>BioCardia, Inc. (Nasdaq: BCDA) announced that the FDA has confirmed and finalized meeting minutes from a pre-submission meeting regarding the company's Helix Transendocardial Delivery Catheter System.</p> <p>The FDA reviewed and accepted minutes submitted by BioCardia in May 2026, which are now considered final. The confirmation aligns with disclosures the company made in a May 8, 2026 press release and an 8-K filing.</p> <p>BioCardia said it plans to submit a follow-on pre-submission for the Helix device during the current quarter, incorporating agency guidance. The company said the submission could support approval through the FDA's De Novo pathway.</p> <p>"We intend to submit the follow-on pre-submission http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html Mon, 24 Aug 2026 08:30:52 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html <p>BioCardia, Inc. (Nasdaq: BCDA) announced that the FDA has confirmed and finalized meeting minutes from a pre-submission meeting regarding the company's Helix Transendocardial Delivery Catheter System.</p> <p>The FDA reviewed and accepted minutes submitted by BioCardia in May 2026, which are now considered final. The confirmation aligns with disclosures the company made in a May 8, 2026 press release and an 8-K filing.</p> <p>BioCardia said it plans to submit a follow-on pre-submission for the Helix device during the current quarter, incorporating agency guidance. The company said the submission could support approval through the FDA's De Novo pathway.</p> <p>"We intend to submit the follow-on pre-submission http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html Mon, 24 Aug 2026 08:30:52 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html <p>BioCardia, Inc. (Nasdaq: BCDA) announced that the FDA has confirmed and finalized meeting minutes from a pre-submission meeting regarding the company's Helix Transendocardial Delivery Catheter System.</p> <p>The FDA reviewed and accepted minutes submitted by BioCardia in May 2026, which are now considered final. The confirmation aligns with disclosures the company made in a May 8, 2026 press release and an 8-K filing.</p> <p>BioCardia said it plans to submit a follow-on pre-submission for the Helix device during the current quarter, incorporating agency guidance. The company said the submission could support approval through the FDA's De Novo pathway.</p> <p>"We intend to submit the follow-on pre-submission http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html Mon, 24 Aug 2026 08:30:52 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html <p>BioCardia, Inc. (Nasdaq: BCDA) announced that the FDA has confirmed and finalized meeting minutes from a pre-submission meeting regarding the company's Helix Transendocardial Delivery Catheter System.</p> <p>The FDA reviewed and accepted minutes submitted by BioCardia in May 2026, which are now considered final. The confirmation aligns with disclosures the company made in a May 8, 2026 press release and an 8-K filing.</p> <p>BioCardia said it plans to submit a follow-on pre-submission for the Helix device during the current quarter, incorporating agency guidance. The company said the submission could support approval through the FDA's De Novo pathway.</p> <p>"We intend to submit the follow-on pre-submission http://www.streetinsider.com/FDA/FDA+confirms+BioCardia+meeting+minutes+on+Helix+catheter+De+Novo+pathway/26964631.html Mon, 24 Aug 2026 08:30:52 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+24/26964627.html si-local-file:///var/storage/secattach/20260824/26964627.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+24/26964627.html Mon, 24 Aug 2026 08:30:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+24/26964627.html si-local-file:///var/storage/secattach/20260824/26964627.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+24/26964627.html Mon, 24 Aug 2026 08:30:00 -0400 BCDA O.00180101 http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Press+Releases/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html <p>SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix).  </p> <p>FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understanding with FDA that BioCardia shared in its May 8, 2026 press release and 8-K filing.</p> <p>“We intend to submit the follow-on pre-submission for Helix incorporating http://www.streetinsider.com/Globe+Newswire/BioCardia+Announces+FDA+Confirms+Helix+Transendocardial+Delivery+Catheter+Meeting+Minutes+Supporting+Follow-On+De+Novo+Pre-Submission+for+Approval/26964610.html Mon, 24 Aug 2026 08:30:00 -0400 A.19651963 BCDA O.00180101 O.21314198 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+19/26961876.html si-local-file:///var/storage/secattach/20260821/26961876.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+19/26961876.html Fri, 21 Aug 2026 16:35:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+19/26961876.html si-local-file:///var/storage/secattach/20260821/26961876.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+19/26961876.html Fri, 21 Aug 2026 16:35:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+17++Filed+by%3A+Altman+Peter/26942955.html si-local-file:///var/storage/secattach/20260818/26942955.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+17++Filed+by%3A+Altman+Peter/26942955.html Tue, 18 Aug 2026 12:14:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+17++Filed+by%3A+Altman+Peter/26942955.html si-local-file:///var/storage/secattach/20260818/26942955.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+17++Filed+by%3A+Altman+Peter/26942955.html Tue, 18 Aug 2026 12:14:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+13++Filed+by%3A+Altman+Peter/26922949.html si-local-file:///var/storage/secattach/20260813/26922949.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+13++Filed+by%3A+Altman+Peter/26922949.html Thu, 13 Aug 2026 17:43:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+13++Filed+by%3A+Altman+Peter/26922949.html si-local-file:///var/storage/secattach/20260813/26922949.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+13++Filed+by%3A+Altman+Peter/26922949.html Thu, 13 Aug 2026 17:43:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+12/26913374.html si-local-file:///var/storage/secattach/20260812/26913374.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+12/26913374.html Wed, 12 Aug 2026 16:27:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+12/26913374.html si-local-file:///var/storage/secattach/20260812/26913374.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++BioCardia%2C+Inc.+++++++++++For%3A+Aug+12/26913374.html Wed, 12 Aug 2026 16:27:00 -0400 BCDA O.00180101 http://www.streetinsider.com/Earnings/BioCardia+%28BCDA%29+Tops+Q2+EPS+by+5c/26913108.html <p>BioCardia (NASDAQ: BCDA) reported Q2 EPS of ($0.13), $0.05 better than the analyst estimate of ($0.18).</p><p>For earnings history and earnings-related data on BioCardia (BCDA) <a href="http://www.streetinsider.com/ec_earnings.php?q=BCDA">click here</a>.</p> http://www.streetinsider.com/Earnings/BioCardia+%28BCDA%29+Tops+Q2+EPS+by+5c/26913108.html Wed, 12 Aug 2026 16:16:38 -0400 BCDA http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++BioCardia%2C+Inc.+++++++++++For%3A+Jun+30/26912946.html si-local-file:///var/storage/secattach/20260812/26912946.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++BioCardia%2C+Inc.+++++++++++For%3A+Jun+30/26912946.html Wed, 12 Aug 2026 16:11:00 -0400 BCDA O.00180101 http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++BioCardia%2C+Inc.+++++++++++For%3A+Jun+30/26912946.html si-local-file:///var/storage/secattach/20260812/26912946.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++BioCardia%2C+Inc.+++++++++++For%3A+Jun+30/26912946.html Wed, 12 Aug 2026 16:11:00 -0400 BCDA O.00180101