Soft-tissue reconstruction company Tela Bio (NSDQ:TELA) announced the appointment of Dr. Bruce Freedman as VP of clinical development. Freedman has practiced 32 years as a general surgeon specializing in hernia repair and abdominal wall reconstruction. He joined Tela Bio after having used its OviTex material in his practice. The Malvern, Penn.-based company’s tech platform is […]
Implants
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
Two former Boston Scientific execs join spine device maker Omnia Medical
Former Boston Scientific (NYSE:BSX) executives Jennifer Martin and Dan Rogers have joined orthopedic implant maker Omnia Medical. Martin, who most recently served as senior director of customer engagement at Boston Scientific, will be the president of Omnia Medical’s new interventional pain therapies division, according to a news release. Rogers joins as VP of sales for the […]
Taking the guesswork out of tracking high blood pressure
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 — […]
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 […]