Second Sight Medical (NSDQ: EYES) today announced that the FDA has approved its Argus 2s retinal prosthesis system, but questions remain about whether it will ever be manufactured. The past year has been tough for Second Sight. The company announced in March 2020 that it would wind down its operations amid the financial shock of […]
Implants
The top 7 medtech CEO quotes on COVID-19, one year later
The latest earnings season has provided insights into the future of medtech in the COVID-19 landscape and what certain sectors are seeing as vaccines start to roll out. Since the start of the pandemic, 113.1 million COVID-19 cases have been reported worldwide, according to Johns Hopkins University School of Medicine. The U.S. leads the world […]
FDA clears G21 SpaceFlex shoulder spacers
G21 today said its SpaceFlex Shoulder modular spacer received FDA 510(k) clearance. SpaceFlex is designed for the treatment of periprosthetic infection to allow for the creation of a modular spacer with G21 antibiotic-loaded bone cement for arthroplasty revision in the operating room. It is ready to use in 15 minutes and surgeons can device on […]
Conformis soars on news of FDA clearance
Conformis (NSDQ:CFMS) recently received FDA 510(k) clearance for its ITotal Identity cruciate-retaining knee replacement system. According to a report from SeekingAlpha, Billerica, Mass.-based Conformis received 510(k) clearance for the ITotal Identity posterior-stabilizing knee replacement system along with the cruciate-retaining knee replacement system. The knee replacements have customized fitting properties with specificity for each patient receiving one. […]
Boston Scientific has another serious recall on the same heart device
The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD). This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may […]
FDA clears FX Solutions stemless anatomic shoulder replacement
FX Solutions today announced that it received FDA 510(k) clearance for its Easytech stemless anatomic shoulder replacement. The Easytech anchor base allows the device to fit peripherally inside the cortical bone where bone quality is optimal for fixation. It is intended to treat a severely painful and/or disabled shoulder joint with a functional rotator cuff […]
Conformis closes $79.6 million offering
Conformis (NSDQ:CFMS) announced today that it closed an underwriting agreement to sell common stock worth approximately $79.6 million. The offering made by the Billerica, Mass.-based company includes the sale of nearly 81 million shares of common stock at a public offering price of $1.05 per share, bringing the expected net proceeds to approximately $79.6 million, according […]
Intersect ENT launches Mini sinus implant
Intersect ENT today announced that it has launched its Straight Delivery System with its Propel Mini Sinus Implant. The combination packaging originally received FDA premarket approval in July 2020. The Straight Delivery System (SDS) is an extension of Intersect ENT’s Propel family of implants that is engineered for precise, consistent and easy delivery of the […]
Longeviti Neuro Solutions ClearFit implant wins FDA clearance for use in ultrasound
Longeviti Neuro Solutions today announced that it received FDA 510(k) clearance or its ClearFit implant for use in ultrasound in post-operative imaging. ClearFit’s FDA clearance allows the device to be used during ultrasound procedures, which carries the risk of radiation exposure with other current post-neurosurgical imaging modalities. “It is our hope that with this new […]
DJO acquires Trilliant Surgical and its foot and ankle implants
DJO announced that it acquired orthopedic foot and ankle implant maker Trilliant Surgical for an undisclosed amount. Dallas-based Colfax (NYSE:CFX) unit DJO’s acquisition is meant to support its focus on expansion into the high-growth U.S. foot and ankle market, which the company touts as a $1 billion market, according to a news release. Trilliant’s product portfolio […]
Tela Bio names clinical development VP
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 […]
