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Mark Hollmer

Organovo inks L’Oreal deal for 3d-printed skin

May 7, 2015 By Mark Hollmer Leave a Comment

Organovo inks L'Oreal deal for 3d-printed skin

Filed Under: Biotech, News Well Tagged With: 3D printing, L'Oreal, Organovo, Tissue Regeneration

FDA withdraws older guidance documents

May 6, 2015 By Mark Hollmer Leave a Comment

FDA withdraws older guidance documents

The FDA is withdrawing 47 draft guidance documents published before the end of 2013 that it never finalized or acted on.

Agency officials posted the announcement in the Federal Register, explaining that the move is designed to boost efficiency and transparency regarding its development of guidance documents.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance

Sorin hopes Perceval valve will rescue flat results

May 6, 2015 By Mark Hollmer Leave a Comment

Sorin hopes Perceval valve will rescue flat results

Filed Under: MassDevice Earnings Roundup, News Well, Replacement Heart Valves Tagged With: 2015, Clinical Trials, Q1, Sorin Group

Diabetes: J&J plans mobile app trial for OneTouch Verio Flex device

May 6, 2015 By Mark Hollmer

Diabetes: J&J plans mobile app trial for OneTouch Verio Flex device

Filed Under: Diabetes, Digital Health, News Well Tagged With: Clinical Trials, Johnson and Johnson, LifeScan Inc.

Medtronic launches new spine devices

May 5, 2015 By Mark Hollmer Leave a Comment

Medtronic launches new spine devices

Medtronic (NYSE:MDT) said it gained 510(k) clearance for 1 spinal repair device and began the commercial rollout of another.

Filed Under: News Well, Regulatory/Compliance, Spine

Oculus Rift heads to the neurosurgery suite

May 4, 2015 By Mark Hollmer Leave a Comment

Oculus Rift heads to the neurosurgery suite

Ohio medtech company Surgical Theater is partnering with UCLA neurosurgeons to incorporate virtual reality video game technology into 1 of its surgical visualization systems.

Filed Under: Neuromodulation/Neurostimulation, News Well, Surgical Tagged With: Oculus VR, Surgical Theater

Axonics generates another $17m

May 4, 2015 By Mark Hollmer Leave a Comment

Axonics generates another $17m

Axonics Modulation Technologies said it raised nearly $17.3 million in an equity financing as it develops next-generation neuromodulation technology to treat various medical conditions.

The California company disclosed the funding in a recent regulatory filing that does not name specific investors.

Filed Under: Funding Roundup, Neuromodulation/Neurostimulation, News Well Tagged With: Axonics Modulation Technologies, Vessix Vascular Inc.

TAVI: U.K. study finds 60% survival rate at 3 years

May 4, 2015 By Mark Hollmer Leave a Comment

TAVI: U.K. study finds 60% survival rate at 3 years

The survival rate for high-risk patients with transcatheter aortic valve implants surpassed 61% at 3 years and drops to 45.5% at 5 years, according to a new analysis of data from the U.K. Transcatheter Aortic Valve Implantation Registry.

Filed Under: News Well, Replacement Heart Valves Tagged With: Clinical Trials, JACC: Cardiovascular Interventions, U.K. Transcatheter Aortic Valve Implantation Registry

Profound Medical goes public in reverse merger

May 1, 2015 By Mark Hollmer Leave a Comment

Profound Medical goes public in reverse merger

Profound Medical yesterday said it’s slated to hit the public markets in Canada after a reverse merger, also revealing a $24 million private placement to fuel clinical trial work.

Filed Under: Mergers & Acquisitions, News Well, Urology, Wall Street Beat Tagged With: Profound Medical Inc.

Hologic raises outlook again after Street-beating Q2

May 1, 2015 By Mark Hollmer Leave a Comment

Hologic raises outlook again after Street-beating Q2

Filed Under: MassDevice Earnings Roundup, News Well, Women's Health Tagged With: 2015, Hologic, Q1

Study: Low-battery defib revisions costly

April 30, 2015 By Mark Hollmer Leave a Comment

Study: Low-battery defib revisions costly

Filed Under: News Well Tagged With: Boston Scientific, Cardiac Rhythm Management, Circulation: Cardiovascular Quality and Outcomes, Clinical Trials

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