Becton, Dickinson and Co. (BD) notched its sixth tuck-in buy of the year, acquiring long-time partner and resorbable polymer maker Tepha Inc. for an undisclosed sum. The deal will facilitate expansion of BD’s surgical mesh offerings and drive growth in new areas of soft tissue repair, reconstruction and regeneration. Wall Street gave the Tepha deal a thumbs up. After hitting a high of $256.32 Tuesday, BD shares (NYSE:BDX) maintained a strong beat, closing up 2.11 at $254.69.
Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.
Synapse Biomedical Inc. has won breakthrough device designation from the FDA for its Transaeris system, a diaphragm pacing system (DPS) for use in weaning patients off mechanical ventilation. The minimally invasive device has been in use during the COVID-19 pandemic under an emergency use authorization to prevent ventilator-induced diaphragm dysfunction – a condition that occurs following mechanical ventilation, which leaves the diaphragm weak from disuse.
Foresight Diagnostics Inc. has developed a circulating tumor DNA (ctDNA) detection platform for detecting minimal residual disease (MRD) in B-cell lymphomas, a form of non-Hodgkin lymphoma and the most common lymphoma in the U.S., accounting for about 85% of all cases. Now, it has published data showing its phased variant enrichment detection sequencing (PhasED-Seq) nearly doubled the identification of patients with aggressive lymphoma who were not cured by standard therapy and need new treatment options.
Fibromyalgia is an often debilitating condition, characterized by chronic pain throughout the body that can leave patients fatigued, depressed and unable to perform even the simplest of activities. While a handful of drugs have been approved to treat this autoimmune disorder, they can have unpleasant side effects and do not benefit all patients. To that end, the FDA has granted a breakthrough device designation to Neurometrix Inc.’s Quell wearable neurostimulation device for treating the symptoms of fibromyalgia in adults.
The FDA has granted breakthrough device designation to Endologix LLC for its Chimney Endovascular Aneurysm Sealing (ChEVAS) system. The device, which is intended for use in treating aortic aneurysms, is currently being evaluated in a multicenter pivotal study. The ChEVAS system is an endovascular abdominal aortic aneurysm (AAA) therapy designed to combine the Nellix 3.5 endograft with parallel visceral chimney stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA.
Myopia, or near-sightedness, is a growing public health problem, often beginning in childhood. Severe cases can lead to serious complications including cataract, glaucoma and retinal detachment. Now, Dopavision GmbH has raised a €12 million (US$14.2 million) series A round to advance its digital childhood myopia therapeutic aimed at nipping this lifelong problem in the bud.
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).
Heartflow Holding Inc. is aiming to bring its noninvasive, artificial intelligence (AI)-based test for coronary heart disease to more doctors and patients via a merger with Longview Acquisition Corp. II. The deal, valued at an enterprise value of about $2.4 billion, is the latest in a steady stream of med techs queueing up to go public via a “blank check” special purpose acquisition company (SPAC) this year.
Pear Therapeutics Inc. released nine-month, real-world data showing long-term reduction in costly health care utilization categories, including inpatient stays and emergency department visits, in patients with opioid use disorder (OUD) who utilize its Reset-O prescription digital therapeutic. The findings suggest that Reset-O could help to stabilize patient outcomes long-term when used in conjunction with outpatient treatment.
