Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey. The 2017 survey – which had 148 respondents in highly regulated industries including medical devices (23%) – found that nearly a quarter of those who answered did not have a well-defined and adopted complaint handling process. Read […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
MiMedx files IND for Ph2 AmnioFix osteoarthritis trial
MiMedx (NSDQ:MDXG) said today that it filed an IND with the FDA for a Phase II trial of its AmnioFix product in patients with osteoarthritis of the knee. The 318-patient study is designed to compare the safety and efficacy of MiMedx’s micronized dehydrated human amnion/chorion membrane (dHACM) injection with a 0.9% sodium chloride USP placebo injection. […]
Pentax Medical wins CE Mark for DEC duodenoscope
Hoya‘s Pentax Medical said today it won CE Mark approval in the European Union for its DEC duodenoscope featuring a disposable elevator cup. The Tokyo-based company said the new device features a combination of advanced cleaning capabilities and improved infection prevention controls to ensure a more reliable performance. The new device also features improved high definition […]
Mevion files for FDA clearance for S250i proton therapy system
Mevion Medical Systems said yesterday it submitted a 510(k) premarket notification to the FDA for its Mevion S250i proton therapy system with Hyperscan pencil beam scanning tech. The Mevion S250i features improved pencil beam scanning fields and Hyperscan pencil beam scanning tech to allow for faster energy layer switching, the Littleton, Mass.-based company said. “We focused […]
FDA approves GSK’s 3-in-1 Trelega Ellipta inhaler
The FDA has approved the triple inhaler developed by GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) to treat chronic obstructive pulmonary disease, the companies reported today. The Trelega Ellipta dry powder inhaler uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD manage the condition. It is the first once-daily product approved in the U.S. that combines three active molecules […]
SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath
SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months. The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction […]
TransEnterix responds to FDA more info request
Robotics medical company TransEnterix filed its response to the Food and Drug Administration’s additional information request on its Senhance Surgical Robotic System 510(k) submission. The Senhance robotic-assisted surgery system is designed to improve minimally invasive surgery, namely in laparoscopy operations, through haptic feedback and eye sensing camera control. Get the full story at our sister […]
Masimo wins FDA nod for Rad-97 pulse oximeter, launches in US
Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for its Rad-97 pulse co-oximeter and launched the device in the US. The Irvine, Calif.-based company said the newly released Rad-97 features NomoLine capnography and noninvasive blood pressure monitoring technology from SunTech Medical, as well as its own continuous monitoring and SET pulse oximetry with upgradable rainbow tech. […]
Arkray launches diabetes diagnostic tech
Arkray‘s U.S. subsidiary launched today its Adams A1c HA-8180V system for hemoglobin A1c testing. The device is indicated to help diagnose and monitor people with diabetes, the Edina, Minn.-based company reported. Get the full story at our sister site, Drug Delivery Business News.
Medtronic wins FDA nod for Intellis SCS, launches in US
Medtronic (NYSE:MDT) said today it won FDA approval for its Intellis implantable spinal cord stimulation system and launched it in the US. The Fridley, Minn.-based company touted the newly revised system as the world’s smallest, and said that the new unit was designed to improve battery performance and standardize guidance and balancing of high-dose and low-dose […]
India’s NPPA says it will not revisit stent price caps until Feb 2018
India’s National Pharmaceutical Pricing Authority said today it won’t be revising its cap on coronary stents, applied earlier this year, until Feb. 2018, according to a LiveMint report. The regulatory body for India established price caps earlier this year that cut prices on coronary stents by over 80%, causing major players in the region to […]