Xenter Inc. has officially launched, positioning itself as the first startup device/data/drug med-tech company. The company is developing wireless solutions for interventional cardiology, interventional radiology and neurointerventional radiology. The company’s goal is to take the medical devices that have been used most ubiquitously throughout medicine, one by one, and replace them with smart technologies that incorporate such things as software, sensors and signals technologies. Read More
The management team at Respinova Ltd. is breathing easier with the FDA's 510(k) clearance of the company's Pulsehaler. Using pulsed air pressure, the device opens airways and clears secretions in patients with respiratory diseases. The clearance represents the device’s first endorsement by a regulatory agency, though the company hopes it will soon be joined by others. Read More
The shortage of hearts for transplant is a matter of record for both cardiologists and patients, a problem that Transmedics Inc. proposed to solve with its Organ Care System (OCS). Despite several significant issues associated with the pivotal clinical study for the OCS, Transmedics snared a 12-5 vote that the benefits of the system outweigh the risks, an outcome that may bring at least some relief for heart transplant patients by mid-year if analyst expectations are on target. Read More
PERTH, Australia – Australia’s TGA issued final guidance on clinical evidence requirements for medical devices in response to updated regulations that have resulted in changes to evidence requirements. Clinical evidence is required for all medical devices and in vitro diagnostics (IVDs) that are listed on the Australian Register of Therapeutic Goods (ARTG). The clinical evidence requirements apply when a device is first listed as well as over the lifecycle of the device. If safety issues are identified, the TGA may ask manufacturers to update clinical information to more accurately reflect risk. Read More
LONDON – The largest study to date, involving 236,379 confirmed cases, shows that 1 in 3 survivors of COVID-19 was diagnosed with a neurological or psychiatric condition within six months of contracting the infection. For 13% of those patients, it was their first such diagnosis. Read More
Med-tech firms raising money in public or private financings, including: Bausch Health, Better Therapeutics, CA Healthcare, Carta Healthcare, CM Life Sciences III, Firefly Health, Lumiradx, Mountain Crest, Orchid, Phreesia, Privia Health Group, Vizgen. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Akili Interactive, Boston Scientific, Cardiac Dimensions, Lumithera, Medcura, Pixium Vision, Protokinetix. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Astrotech, Atai Life Sciences, Breathtech, Johnson & Johnson Vision, Manta, Medical Information Technology, Menicon, Natera, Newomics, Nicoya Lifesciences, Opsens, Psyber, Premier Medical, Qiagen, Roche, Titan Health & Security Technologies, Vizient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Chemence Medical, Nuvasive, Vitro Biopharma. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization. Read More
Keeping you up to date on recent developments in orthopedics, including: New study expands evaluation of gene therapy for spinal muscular atrophy; High risk of AKI in patients undergoing treatment for infected total knee replacement; Tadpole nerve regeneration capacity provides clue to treating spinal cord injury. Read More
