Startup CoraVie Medical aims to give patients and their physicians better control over hypertension with a tiny implantable device. Aimee Garza wants to do for high blood pressure what continuous glucose monitors are doing for diabetes. The veteran medtech engineer and marketing maven brings 25 years of experience at two of medtech’s biggest companies — […]
Implants
FDA clears first torn-ACL implant
Connective tissue repair implant maker Miach Orthopaedics announced that it received FDA de novo clearance for its ACL repair implant. Westborough, Mass.-based Miach said today in a news release that its Bridge-Enhanced ACL repair — BEAR — implant received the de novo marketing approval for treating anterior cruciate ligament (ACL) tears. BEAR is touted as the […]
Supremes turn back Cochlear IP appeal
The U.S. Supreme Court has declined to hear a $268 million patent case appeal filed by Cochlear Ltd. (ASX:COH) against two competitors. The Australia-based hearing implant company had appealed a March 2020 federal appeals court decision upholding a U.S. District Court decision that awarded $268 million in damages to those competitors, the Alfred Mann Foundation and Advanced Bionics, the […]
NuVasive updates scoliosis device recall
NuVasive (NSDQ:NUVA) issued a voluntary field safety notice in Europe to warn of an issue with its Magec scoliosis treatment device. The Magec system is a metallic spinal implant designed for bracing the spine during growth to minimize the progression of scoliosis. Instructions for use of the device indicate that the implants can loosen, fracture, corrode, […]
Medical Ingenuities gains FDA nod for radial artery occlusion device
Medical Ingenuities today received FDA 510(k) clearance for its radial artery occlusion device called PH Band. PH Band provides real-time feedback to medical personnel monitoring radial artery patency to help prevent radial artery occlusion, according to the Wheaton, Ill.-based company. It can be used in conjunction with a micro Doppler Probe to achieve patent hemostasis […]
Vectorious’ in-heart microcomputer wins FDA breakthrough nod
Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s left atrial pressure (LAP) monitoring device. The V-LAP system is the first digital, wireless, battery-free device that can communicate from deep within the body using high-resolution waveform morphology, according to the Tel Aviv-based startup. Because the pressure of the […]
FDA approves Boston Scientific’s Ranger drug-coated balloon
Boston Scientific (NYSE:BSX) today said it received FDA approval for its Ranger drug-coated balloon for peripheral artery disease. The balloon’s creators designed it to treat peripheral artery disease (PAD) in the superficial femoral artery and proximal popliteal artery — with a low therapeutic drug dose and coating to transfer the drug into the tissue. Get the […]
DTW Podcast: Hear the future of AI, 3D, and Dx from Edwards, Stryker, Evercore, Checkable
In this week’s episode of DeviceTalks Weekly we review the Medical Design & Outsourcing’s Women in Medtech issue — bringing you insights through interviews with Katie Syzman, corporate VP and the GM of critical care at Edwards Lifesciences, Naomi Murray, Stryker’s director of advanced operations, and Patty Post, CEO of Startup Checkable Medical. Szyman […]
MEDX Xelerator expands startup portfolio
Israel-based medical device and digital health incubator MEDX Xelerator today announced it has added three new companies to its portfolio: Dimoveo Medical, a developer of ultrasound-based infection treatment and prevention. Swift Duct, a company working to reduce the incidence of post-endoscopic retrograde cholangial-pancreatography (ERCP) pancreatitis. Synchrony Medical, a creator of a respiratory therapy device to aid patients […]
Cook Medical announces U.S. launch of balloon for transnasal esophageal procedures
Cook Medical today commercially launched its Hercules 100 Transnasal Esophageal Balloon in the U.S. The balloon is designed specifically for trans nasal esophageal procedures and is another tool for ENT physicians to help treat esophageal strictures. “This balloon was specifically designed with ENT physicians and their patients in mind. The balloon is much shorter than […]
Abiomed touts latest Impella trial results
Abiomed (NSDQ:ABMD) today announced interim results of a study that found high-risk patients had better outcomes after implantation with its Impella CP heart pump. Data from the PROTECT III FDA post-approval study of Impella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI) patients showed reduced rates of MACCE — a composite of death, stroke, […]