MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR system. The FDA IDE nod for the novel sirolimus-eluting balloon allows MedAlliance to initiate a pivotal clinical trial for use of Selution SLR in the treatment of occlusive disease of the superficial femoral artery (SFA). Geneva, Switzerland-based MedAlliance’s second IDE […]
FDA
FDA approves first targeted infusion therapy for HER2-low breast cancer
The FDA announced today that it approved Enhertu, an IV infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Enhertu (fam-trastuzumab-deruxtecan-nxki) IV infusion is now the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. The therapy received […]
Dexcom to update next-gen G7 software, delaying FDA clearance, launch timelines
The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed. Speaking on the continuous glucose monitor (CGM) maker’s second-quarter earnings call, Dexcom Chair, President and CEO Kevin Sayer explained that the company has — based on feedback from the FDA — been tweaking the software […]
ICU Medical’s Smiths Medical has a Class I infusion pump recall
The FDA has issued a notice classifying a recall of infusion pumps from Smiths Medical as Class I, the most serious kind. Smiths Medical — which was acquired by ICU Medical in January for $2.35 billion — earlier this month issued a warning in Europe for the same reason: eight potential issues with its Medfusion […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound to […]
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]
FDA clears Abbott’s next-gen FreeStyle Libre 3 14-day CGM
Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous glucose monitor. FDA clearance for the latest iteration of the company’s FreeStyle Libre platform — designed as the smallest and thinnest CGM sensor in the world — covers use by people 4 years of age and older living with […]
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A lot of talk around Dexcom (Nasdaq:DXCM) in the last couple of years has centered around its next-generation G7 continuous glucose monitor. The latest iteration of the company’s CGM platform has already garnered CE mark this year and awaits FDA approval, with some expectations for that to come after the American Diabetes Association’s Scientific Sessions […]
FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases. […]
FDA grants STeP designation for Pear Therapeutics’ neurobehavioral digital therapeutic
Pear Therapeutics (Nasdaq:PEAR) announced today that it received STeP designation from the FDA for its Pear-010 product candidate. Boston-based Pear Therapeutics designed its Pear-010 prescription digital therapeutic (PDT) candidate to provide a neurobehavioral intervention (virtual reality-delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. Get the full story at our […]