Medicare coverage does not necessarily mean appropriate reimbursement levels, a point pressed by Inspire Medical Systems Inc. at the Aug. 23 Medicare outpatient advisory panel hearing. The panel agreed that the company’s hypoglossal nerve stimulation (HNS) device for sleep apnea was subject to an inappropriate device offset figure, which could lead to a Medicare rate increase of more than $7,000 and a significant boost of sales of the company’s flagship Inspire HNS device. Read More
As the U.S. House of Representatives resumes work Aug. 23 on a budget reconciliation proposal to get a $3.5 trillion fiscal 2022 budget across the finish line, many lawmakers are looking to provisions to reduce prescription drug prices as a way to pay for increased spending in other health care sectors. Read More
Shanghai Heartcare Medical Technology Co. Ltd. shares took a hard fall in their Aug. 20 debut on the Hong Kong Stock Exchange (HKSE), closing at HK$129 (US$107.47) after tumbling all the way down to HK$127.8 earlier in the day. Read More
PERTH, Australia – The Australian government is investing AU$79 million (US$56.75 million) in medical research and innovation projects to develop new drugs, devices and digital health technologies through its AU$20 billion Medical Research Future Fund (MRFF). Read More
The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement. Read More
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beeline, Cynergi Health Partners, Lightpoint Medical, Neupath Health, Opum, Provista Diagnostics, Thuasne Group, Todos Medical, Veon. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Shoulder Innovations. Read More
