Boston Scientific Corp., of Marlborough, Mass., has won the U.S. FDA’s nod for the Exalt Model D single-use duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. It is the first single-use duodenoscope on the market and earlier secured breakthrough device designation. “Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

Perkinelmer Inc., of Waltham, Mass., has won a thumbs up from the U.S. FDA for its GSP Neonatal Creatine Kinase-MM kit. The assay is the first test approved in the U.S. for help in screening newborns for Duchenne muscular dystrophy (DMD), a rare but devastating genetic disorder. While there is no known cure for DMD, earlier screening and diagnosis could lead to improvements in quality of life by enabling earlier and more personalized treatment of symptoms. The kit’s approval opens the door for states to include DMD among the battery of tests newborns typically undergo, such as phenylketonuria, cystic fibrosis and congenital heart disease.

LONDON – Dutch startup Enzyre BV is teaming up with Takeda Pharmaceutical Co. Ltd. to complete development of a home diagnostic device that aims to make it as easy for hemophiliacs to self-test their coagulation status as it is for diabetics to monitor their blood sugar levels.

A pair of Israeli health tech companies, Beyond Verbal and Healthymize, plan to merge to form Newton, Mass.-based Vocalis Health. The company will be focused on developing vocal biomarkers, which track voice patterns via phone calls or smart devices to screen for various voice-indicating ailments including chronic respiratory and cardiac conditions, as well as depression. Vocalis has raised a $9 million financing led by Israeli health tech and life science venture firm Amoon to accumulate additional clinical data and enhance its voice database.

TORONTO – Synaptive Medical Inc. has completed the first round of a new preferred equity investment totaling $25 million led by Guelph-Ontario-based Linamar Corp., which also entered into a manufacturing agreement with Synaptive, and Calgary’s Audible Capital Corp.

As part of newly announced collaborations with Cleveland-based Viewray Inc., Elekta AB assumed a 9.9% stake in the company, and Medtronic plc also made a minority investment. The company's largest shareholder, Fosun International Ltd., also led the round. "In total, the company raised approximately $139 million, net of fees," Viewray President and CEO Scott Drake told BioWorld MedTech.

Menlo Park, Calif.-based Akoya Biosciences Inc. has scooped up $50 million in financing, with an eye toward growing via the expansion of commercial and operational resources and continuing product development activities around its platforms for spatial biology.

Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.