
Top 3 reasons your 510(k) submission was rejected – Part I

The Medical Device Business Journal — Medical Device News & Articles | MassDevice
New Minnetronix CFO started yesterday
The new CFO of Minnetronix, Phil Ankeny, joined the company today. Ankeny moved over to Minnetronix from SurModics Inc., where he served as interim CEO and CFO. His background is in venture capital, IT startups and investment banking.
RESTON, Va.–(BUSINESS WIRE)–Aptiv Solutions, a biopharmaceutical and medical device development services company, and the leader in adaptive clinical trial design, simulation and execution, announces the completion of a key milestone in the development of a new platform for phase Ib and II adaptive design clinical trials.
Reston, Va.-based Aptiv Solutions opened new office in North Carolina, where it plans to hire more staff and combine Aptiv Solutions and its subsidiary Trio Clinical Resourcing under 1 roof.
Aptiv offers biopharmaceutical and medtech development services, including clinical trial design and execution as well as medical device consulting and trial execution.
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Roy Malkin, the former CEO of Minntech Corp. who was seriously injured last spring in a plane crash, has been back with the company on a limited basis since September, according to a regulatory filing.
Malkin’s private single-jet plane crashed in early June in Crystal, Minn., as the plane was attempting to take off.
NuVasive (NSDQ:NUVA) closed its $80 million pickup of Impulse Monitoring Inc. last week, according to a filing with the federal Securities & Exchange Commission.
The deal, which closed Oct. 7, saw IMI’s shareholders receive nearly $40.5 million in cash and more than 2.3 million shares of NuVasive common stock with an aggregate value of about $40.5 million (per NUVA’s Oct. 6 closing share price of $17.32).
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Life sciences consulting company Aptiv Solutions announced that it acquired Medical Device Consultants Inc., broadening its reach in medical device regulation and strategy.
North Attleboro, Mass.-based regulatory consulting and clinical research organization MDCI has been around since 1980, offering regulatory and clinical services to the med-tech sector.
The North Carolina CRO that launched as Trio Clinical Research is moving forward with a new name and a different strategy.
Trio changed its official name to Trio Clinical Resourcing, a change that reflects the Raleigh, N.C.-based CRO’s focus on providing recruiting and staffing services to biotechnology, pharmaceutical and medical device companies, according to Trio.