MASSDEVICE ON CALL — Attendees at the IBF MedTEch Investing Conference in Minneapolis weren’t put off by predictions that only 10 U.S. startups seeking PMA’s from the Food & Drug Administration will win venture capital backing this year.
Despite a highly competitive and seemingly dire market, startups can still finding funding.
Startups should consider strategic deals with angel and super angel investors, strategic partnerships with corporate acquirers and early stage funds from public money, conference attendees said.
"That’s as good as raising money," Peter Bianco, who advises early stage firms and specializes in the orthopedics space, told MedCity News.
Pre-revenue companies or those that have recently formed shouldn’t rely on VC to raise money, "unless they have something that’s really unique with a perfect business model, a perfect management and a really short path to market, and there arena’t very many deals like that," Bianco said.
FDA: Mind the gap
The U.S. Government Accountability Office, the investigative arm of the U.S. Congress., renewed last year’s criticisms of the Center for Devices & Radiologic Health, the branch of the Food & Drug Administration responsible for overseeing medical devices.
The FDA’s recall process is prone to gaps that "may increase the risk that unsafe medical devices could remain on the market," according to the report.The FDA was also chided for being slow to review recalls and for not taking measures to meaningfully analyze them.
The report was submitted as testimony in an April hearing of the Senate Special committee on Aging.
Former NASDAQ exec. pleads guilty to insider trading
The federal crackdown on insider trading implicated former Nasdaq Stock Market executive Donald Johnson, who pleaded guilty to securities fraud for insider trading.
Johnson pulled more than $755,000 in illegal profits trading online in his wife’s name, while he worked at the Nasdaq Market Intelligence Desk, according to the SEC filing. Johnson received advance word of corporate developments in order to help companies determine how changes would affect trading in their stock.
Johnson, who retired from Nasdaq in 2009, could receive a maximum of 20 years in prison and a $5 million fine, Neil MacBride, U.S. attorney for the Eastern District of Virginia told the The Washington Post.
First round of CMS electronic health record payments total $75 million
The Centers for Medicare & Medicaid Services announced that payments totaling $75 million were to providers who signed up for the EHR Incentive program. The funds were distributed to the more than 280 providers who signed up during the first two weeks of the program, according to a CMS release.
Johns Hopkins wins $10 million for patient safety institute
Johns Hopkins received a $10 million gift from chairman of the board of trustees Michael Armstrong. The funds will go to the Armstrong Institute for Patient Safety and Quality, which will conduct research and develop methods to help prevent infections, misdiagnoses and other hospital errors.
