Varian sells 20 new radiosurgery systems to U.K. healthcare regulators
The British NHS Supply Chain bought 20 of Varian Medical Systems‘ (NYSE:VAR) TrueBeam devices as part of a planned upgrade of radiotherapy and radiosurgery systems in the nation’s hospitals.
AtriCure widens exclusive contract with Japanese distributor
Class action lawsuit accuses Biolase and officers of lying to investors
Texas spinal devices maker LDR Holding shoots for IPO of up to $69M
LDR Holding Corp. announced that it’s making a bid for its initial public offering, aiming to sell its stock on the NASDAQ global market under the stock ticker ‘LDRH’, according to a company statement.
The company Texas-based spinal device company did not disclose the number of shares or detailed pricing for the IPO, but filed for an offering of up to $69 million, SEC documents show.
Cardium takes another swing at FDA clearance for wound care product
Cardium Therapeutics (NYSE:CXM) appealed to U.S. federal regulators for 510(k) clearance of its Excellagen wound care product after making several modifications and including more specific labeling.
Baird invests in China’s Kedu Healthcare
Baird Capital invested in the Chinese medical device supplier Kedu Healthcare, sending over a new board member as part of the deal. The healthcare investment firm kept quiet about the amount of cash involved in the deal.
The FDA’s lab rules don’t apply to early-stage research | MassDevice.com On Call
MASSDEVICE ON CALL — U.S. federal regulators cleared up some questions for medical device companies about "good laboratory practice," making it clear that the agency’s tougher standards don’t apply in very early-stage research.
The FDA clarified that, when testing a device for basic effectiveness, companies do not need to abide by the more strict quality guidelines that apply to later-stage work.
Biomet’s preemption bid fails, company proceeds to trial over metal hips
Biomet will go to bat over its M2A-magnum metal-on-metal hip implants after failing to convince an Indiana federal judge that a personal injury lawsuit was preempted by FDA rules.
FDA clears Dallen Medical’s compression for sternal closure
The FDA cleared a next-generation sternum compression band made by California bone repair company Dallen Medical. The company’s Compressyn Band, used for breastbone closure, features a new polymer coating that older lines of the Compressyn products lack.
IRS nails down individual mandate non-compliance fines | MassDevice.com On Call
MASSDEVICE ON CALL — The IRS this week published detailed rules for the individual insurance mandate , finalizing the law’s penalty for noncompliance.
In the 1st year without insurance the fine will be $95, or 1% of household income. Subsequently, the fine will increase to $695 per person, or 2.5% of household income, and then adjust to the cost of living along those lines.