The Medical Device Business Journal — Medical Device News & Articles | MassDevice
iCad Inc. got pre-market approval from the Food & Drug Administration for software it says will locate the best point to perform a needle biopsy of the breast.
The Nashua, N.H.-based computer-aided detection products maker said its PrecisionPoint product won 510(k) pre-market notification clearance from the federal watchdog agency March 31.
PrecisionPoint will be integrated into iCad’s CADvue breast MRI image review software.
Waters Corp. inked a pact with England’s University of Warwick to develop mass spectrometry technoliges at a new research center funded by the Milford-based laboratory instruments maker.
The “Waters Centre for BioMedical Mass Spectrometry” at the university will provide scientists with access to state-of-the-art MS and liquid chromatography techniques.
BioSphere Medical Inc. inked a deal with Nippon Kayaku Co. Ltd. to distribute two of its products in Japan.
The Rockland-based biotech firm said Nippon Kayaku will distribute its HepaSphere and Embosphere products, tiny “microspheres” used in embolotherapy procedures to treat uterine fibroids, hyper-vascularized tumors and vascular defects.
The terms of the deal call for the Japanese firm to handle and pay for the regulatory process there, “including performing any clinical studies that may be required as a condition to product registration.”
Bruker Group said it expects a “single digit revenue decline” when it releases financial results for the 2009 first quarter in late April, company officials told analysts at the JP Morgan investor conference in New York.
Orthofix International is one of the companies named in a whistleblower lawsuit accusing the group of bone-growth stimulator manufacturers of reimbursement fraud.
It’s not the first time the Boston-based orthopedics maker has run afoul of federal authorities and the False Claims Act. In 2003, the company agreed to pony up nearly $1.6 million to settle allegations that it submitted false claims to TRICARE, the military’s healthcare program.
What is the basic goal of venture capital? The answer is generally pretty straightforward: Trade cash for equity in companies with the hope of realizing outsized returns on those investments.
Isn’t that pretty much what hedge funds do? If both groups try to do the same thing, then shouldn’t they be regulated the same way?
I think this must have been U.S. Treasury Secretary Timothy Geithner’s line of reasoning during his recent testimony before Congress.
Cynosure Inc. is bracing for another hard landing after predicting a 60 percent revenue plunge for the first quarter of 2009.
The sales drop pushed the Westford-based cosmetic laser products maker into the red and forced officials to lay off 25 employees, about 10 percent of its total workforce.
CEO Michael Davin said the cuts were offset by the addition of 11 employees hired to open a direct sales office in Korea; accounting for the layoffs and new hires, the company has 271 workers worldwide, down from 288 at the end of 2008.
U.S. Attorney Michael Sullivan is making his last week on the job a busy one.
Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.
The Food and Drug Administration issued a Class 1 recall for one of Teleflex Medical‘s balloon pump catheters, due to a problem with the device’s electronic volume setting.
The federal watchdog agency said it received 25 complaints, but no reports of injuries, about a problem it described as a faulty volume connection for the Everett-based company’s 30cc, 40cc and 50cc Intra Aortic Balloon Pump catheters made by its Arrow International subsidiary.
Intrinsic Therapeutics Inc.‘s spinal device got the nod from European Union regulators.
The Woburn orthopedic device maker’s Barricaid annular prosthesis won CE mark approval from the European Union, meaning it’s cleared to hit the market across the pond.
The device is a partial-disc prosthesis that enables surgeons to reconstruct the annulus (a fibrous ring around the edge of the intervertebral disc) during standard discectomies in patients with lumbar disc herniations and sciatica.
American Well landed its second contract with Blue Cross, Blue Shield, this time to provide its Online Care service to the healthcare provider’s Minnesota operation.
The Boston-based online healthcare services provider‘s first deal, inked last year, was with the healthcare provider’s Hawaii operation.
Online Care is a multimedia web interface that allows patients to virtually consult with physicians over the Internet.
