Si-Bone (Nasdaq:SIBN) announced today that it received additional FDA clearance for its iFuse Bedrock Granite implant. New indications for the implant include its use with a range of commercially available pedicle screw systems. Santa Clara, California-based Si-Bone received FDA 510(k) clearance for iFuse Bedrock Granite for spinal procedures in May. It designed the implant to […]
Invacare draws additional $5.5M in term loans
Invacare (NYSE:IVC) announced today that it consummated an additional draw of $5.5 million in term loans under a credit agreement. The maker of wheelchairs, mobility scootera and more took the additional draw under its credit agreement, with funds managed by Highbridge Capital Management managed the funds. It took place on Dec. 23, 2022. Elyria, Ohio-based […]
ITC rules in favor of AliveCor in patent spat with Apple
AliveCor announced today that the International Trade Commission (ITC) ruled that the Apple Watch infringed its patented technology. Along with the final determination, the ITC issued a limited exclusion disorder (LEO) and a cease and desist order. It set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold […]
BioTelemetry, CardioNet to pay nearly $45M to resolve False Claims Act violation allegations
BioTelemetry and its CardioNet subsidiary agreed to pay $44.875 million to resolve False Claims Act violation allegations. Both companies now belong to Philips after it acquired BioTelemetry for $2.8 billion last year. The U.S. Department of Justice alleged that the companies knowingly submitted false claims surrounding heart monitoring tests. DOJ claims the companies submitted claims […]
Eyenovia unveils digital ocular drug delivery device
Eyenovia (Nasdaq:EYEN) announced today that it is developing a microdosing system to facilitate the digital delivery of eye medications. New York-based Eyenovia develops a pipeline of late-stage microdose array print (MAP) therapeutics. It aims for this system to improve the overall patient experience and streamline practice flow. Get the full story at our sister site, […]
Data backs Orthofix cellular bone allograft for lumbar fusion
Orthofix (Nasdaq:OFIX) today announced positive results from a clinical study evaluating its Trinity Elite cellular bone allograft (CBA). The prospective, multicenter study evaluates the Orthofix Trinity Elite in lumbar spinal fusion procedures. It demonstrated fusion rates of 98.6%, measured by bridging bone at 12 months follow-up. Investigators published the study results in Neurology International. “The […]
Pavmed, Novosound partner on catheter-delivered ultrasound tech
PAVmed (Nasdaq:PAVM) announced today that it entered into a license option and joint R&D agreement with Novosound. Glasgow, Scotland-based Novosound develops proprietary flexible thin-film ultrasound technology for medical imaging. The venture-backed company currently targets next-generation intravascular ultrasound (IVUS) imaging. “Nearly all of the advances in ultrasound imaging technology over the past several decades have focused […]
Rewalk Robotics extends share repurchase program
ReWalk Robotics (Nasdaq:RWLK) announced today that its board of directors approved an extension to its current share repurchase program. Yokneam Ilit, Israel-based ReWalk values its ordinary shares at NIS 0.25 ($0.072) apiece. This brings the program extension to an aggregate amount of up to $5.8 million. ReWalk’s ongoing $8 million repurchase program received approval from […]
Johnson & Johnson completes $16.6B Abiomed acquisition
Johnson & Johnson (NYSE:JNJ) announced today that it completed its $16.6 billion acquisition of Abiomed (Nasdaq:ABMD). Abiomed now becomes part of Johnson & Johnson, operating as a standalone business within its MedTech segment. “We are excited to officially welcome the talented Abiomed team to Johnson & Johnson. Their patient-first philosophy aligns with our credo and our […]
FDA clearance for Dexcom G7 marks a ‘huge leap’ forward, COO Jake Leach says
After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here. In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high. About […]
MassMEDIC announces ‘record-breaking’ year
The Massachusetts Medical Device Industry Council (MassMEDIC) announced that 2022 represented a “record-breaking” year. Among the organization’s 2022 accomplishments, MassMEDIC grew its staff as in-person events returned. It also launched its “Why Medtech” campaign and advocated for its more than 300 members ranging from Beacon Hill to Washington, D.C. “The past year has been transformational […]