Baltimore-based Coaptech LLC won a green light from the U.S. FDA for its PUMA-G system, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes. The PUMA-G system is the first application of the company's Point-of-care Ultrasound Magnet Aligned (PUMA) system platform, which enables ultrasound to work in hollow organs of the body for diagnostic or interventional procedures.
Warsaw, Ind.-based Zimmer Biomet Holdings Inc. yet again beat expectations as its ongoing turnaround continues. Specifically, the company saw first-quarter net sales of $1.976 billion. As a result of the effect of foreign currency exchange negatively affected sales by 2.8%, resulting in a reported net sales decrease of 2.1% from the prior-year period. The revenue figure came in above Wells Fargo's estimate by $17 million and consensus by $11 million, Larry Biegelsen wrote.
Boston Scientific Corp., of Marlborough, Mass., took a slight hit Wednesday in the wake of reporting first-quarter results, that despite revealing the day before that it had received U.S. FDA approval for the Lotus Edge aortic valve system.
Onera Health Inc. has raised $9.3 million in a series A funding round, which was led by Ireland-based Jazz Pharmaceuticals plc, Imec.xpand, as well as other investors including Imec and the Brabant Development Agency. The company, which is based in Silicon Valley and has R&D offices in the Netherlands, is focused on sleep diagnostics with an at-home medical-grade sleep diagnostic patch system.
The U.S. FDA has given its final approval to the first generic Narcan (naloxone hydrochloride) nasal spray to stop or reverse the effects of an opioid overdose. It marks the latest step in the agency's efforts to combat the opioid crisis. The agency tentatively approved this product from Teva Pharmaceuticals USA Inc. June 8, 2018. Parent Teva Pharmaceutical Industries Ltd. is located in Petach Tikva, Israel.
The U.S. FDA has given its final approval to the first generic Narcan (naloxone hydrochloride) nasal spray to stop or reverse the effects of an opioid overdose. It marks the latest step in the agency's efforts to combat the opioid crisis. The agency tentatively approved the product from Teva Pharmaceuticals USA Inc. June 8, 2018. Parent Teva Pharmaceutical Industries Ltd. is located in Petach Tikva, Israel.
Angiodynamics Inc., of Latham, N.Y., entered a definitive agreement to sell its Namic fluid management portfolio to Northfield, Ill.-based Medline Industries Inc. for $167.5 million, subject to customary closing conditions. The transaction is expected to wrap up by the end of Angiodynamics' fiscal year.
