Stryker Corp. has won the FDA’s nod for an implantable balloon spacer to aid in the healing of torn rotator cuffs. The de novo clearance of the Inspace subacromial tissue spacer system comes more than a decade after the biodegradable shoulder repair implant first debuted in European markets. The minimally invasive Inspace device is intended for arthroscopy treatment of massive irreparable rotator cuff tears (MIRCTs). Read More
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs. Read More
Sonde Health struck a deal with Qualcomm Technologies Inc. to embed its vocal health biomarker product, Sonde One, in the Snapdragon 888 and 778G 5G mobile platforms. The deal would make vocal biomarker monitoring native to the devices that use the company’s chips in mobile and IoT devices. Read More
The COVID-19 pandemic may have been largely responsible for the lower volume of enforcement activities against device makers in 2020, but the volume of these activities seems to be ramping up in 2021. Recently, the FDA posted a large batch of warning letters to device makers while the U.S. Department of Justice (DoJ) announced two new enforcement actions, including a $27 million fine to the operators of durable medical equipment distributorships for kickbacks, part of a growing set of signals that enforcement is back in vogue in the U.S. Read More
TORONTO – Spino Modulation Inc., a subsidiary of Montreal-based med-tech company Spinologics Inc., has received breakthrough device designation for a vertebral body tethering (VBT) device to treat adolescent idiopathic scoliosis, one of three types of scoliosis that cause the spine to develop an abnormal curve. Read More
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Airstrip, Avita Biomedical, Biointellisense, Exactech, International Isotopes, Invivo Therapeutics, Radqual, RTI Surgical, Seegene, Symphonyai. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: East End Medical, Stryker, Xenios. Read More
