Smith & Nephew (NYSE:SNN) announced today that its Regeneten bioinductive implant for rotator cuff procedures received CE Mark approval in Europe. Regeneten, a collagen-based implant, supports the body’s natural healing process by inducing the growth of new tendon-like tissue to biologically augment the existing tendon and disrupt disease progression. The implant, which is the size of […]
Implants
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
Aesculap launches hydrocephalus valve
Aesculap recently launched its M.blue hydrocephalus valve. The valve is adjustable gravitational valve that features an integrated fixed pressure differential valve during the most active time of the day, according to the company. The fixed pressure differential valve addresses posture changes. “We are very pleased to be able to continue to provide healthcare teams with […]
Allergan, Ideal Implant targets of FDA warning letters
The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements. One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of […]
Second Sight prices public offering
Second Sight Medical (NSDQ:EYES) announced that it priced an underwritten public offering with expected gross proceeds reaching $7.5 million. The maker of visual prosthetic implants for blind individuals announced in March that it was winding down its operations amid the financial shock of the COVID-19 pandemic. At the time, the company said it would lay off […]
These medical devices are getting ready to launch in 2020
Despite the COVID-19 pandemic, medical device companies are still working to gain regulatory approvals and launch new devices this year. The pandemic has largely fixed the FDA’s focus on emergency use authorizations (EUAs), leaving more typical device approvals waiting. At press time, the regulatory agency had granted 84 EUAs beginning Feb. 4 and had approved […]
COVID-19 upends medtech’s financial outlook
The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]
Medtronic’s Pipeline Flex recall is Class I
The FDA has labeled a recall for the Medtronic (NYSE:MDT) Pipeline Flex embolization device and Pipeline Flex embolization device with Shield technology as Class I. Medtronic wrote to customers risk of device fracture in February and later issued an urgent field safety notice to warn on specific production lots. The affected Pipeline Flex devices are available […]
Neocis seeks 510(k) nod for Yomi edentulous splint for robotic dental surgery
Neocis announced today that it filed for FDA 510(k) clearance for its Yomi edentulous splint to aid its dental robotic surgical system. The Miami-based company’s new splint is designed to enable the Yomi dental robotic system to go beyond placing implants for partially edentulous patients, with new capabilities for assisting doctors with full arch implant […]
FDA approves BioStage’s esophageal device investigational new drug application
Biostage (NSDQ:BSTG) this week announced that its Cellspan Esophageal Implant investigational new drug application won FDA approval. The Cellspan Esophageal Implant is designed to treat patients with end-stage esophageal disease that require segmental surgical resection to repair diseased tissue. Biostage announced the first patient was treated with the esophageal implant in August 2017. The device was […]
NuVasive recalls scoliosis treatment devices
NuVasive (NSDQ:NUVA) issued an urgent field safety notice to warn users of an issue with the separation of a certain component in its Magec system model X rods. According to the safety notice, post-implant separation of an actuator end cap component was observed in the rods. Data from post-market surveillance revealed that the end cap separation […]