enVVeno Medical (Nasdaq:NVNO) announced today that it received FDA investigational device exemption (IDE) for its enVVe system. The IDE allows Irvine, California–based enVVeno (formerly Hancock Jaffe) to begin the TAVVE pivotal trial for the system. It represents a first-in-class minimally invasive, non-surgical replacement venous valve for … [Read more...] about enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve
Regulatory
Total Flow Medical earns FDA nod for femoral arterial cannula for cardiopulmonary bypass
Total Flow Medical announced today that it received FDA 510(k) clearance for its TFA femoral arterial cannula device. Vancouver-based Total Flow Medical's TFA cannula received clearance for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours. Femoral arterial cannulation, a commonly used technique for … [Read more...] about Total Flow Medical earns FDA nod for femoral arterial cannula for cardiopulmonary bypass
FDA warns on percutaneous catheter issue from Boston Scientific
The FDA today issued an early notice after Boston Scientific (NYSE:BSX) recommended the removal of certain percutaneous catheter systems. In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers … [Read more...] about FDA warns on percutaneous catheter issue from Boston Scientific
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the … [Read more...] about Baxter warns on intravascular administration sets
Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Medtronic (NYSE:MDT) has issued a letter to affected customers recommending the removal of certain lots of its Harmony delivery catheter system (DCS). In a notice published by the FDA, the agency said Medtronic's recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could … [Read more...] about Medtronic warns on Harmony transcatheter pulmonary valve delivery system
Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Abbott (NYSE:ABT) announced today that the FDA approved the longer length (76 mm) Esprit BTK drug-eluting scaffold system. The longer Esprit BTK system received approval for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD). CLTI can cause extreme pain, open wounds that don’t heal and, … [Read more...] about Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Johnson & Johnson (NYSE:JNJ) announced today that it received FDA approval for its dual-energy ThermoCool SmartTouch SF platform (DE STSF). The ThermoCool SmartTouch platform combines the ThermoCool SmartTouch SF catheter with the TruPulse generator. Combining the irrigated contact-force-sensing catheter with TruPulse enables the delivery of … [Read more...] about Johnson & Johnson wins FDA approval for ThermoCool SmartTouch dual-energy ablation system
Terumo initiates voluntary thoracic stent graft recall after 3 deaths
Terumo announced today that it initiated a voluntary recall of specific models of its Relay Pro thoracic stent graft system. Affected products include the Relay Pro NBS (non-bare stent) models with diameters ranging from 32 mm to 46 mm. The recall spans approximately 7,000 affected units sold between May 2024 and March 2026. Tokyo-based Terumo … [Read more...] about Terumo initiates voluntary thoracic stent graft recall after 3 deaths
StarMed wins FDA clearance for RF ablation platform for thyroid nodules
StarMed announced today that it received FDA 510(k) clearance for its platform that delivers radiofrequency (RF) ablation of thyroid nodules. The company said this clearance makes it the first and only one with an FDA indication for RF ablation of thyroid nodules. Until now, according to StarMed, patients requiring thyroid nodule intervention … [Read more...] about StarMed wins FDA clearance for RF ablation platform for thyroid nodules
Artivion earns FDA nod for aortic arch prosthesis device
Artivion (NYSE:AORT) announced today that it received FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis device. The approval covers acute Debakey Type 1 aortic dissections with either clinical or radiographic malperfusion. Atlanta-based Artivion estimates that this population comprises approximately 60% of all Debakey Type 1 aortic … [Read more...] about Artivion earns FDA nod for aortic arch prosthesis device
