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Gov. Deval Patrick's life sciences legacy

MassDevice.com looks at the life sciences legacy of former Massachusetts Gov. Deval Patrick.

Weight loss: ReShape Medical's Duo balloon system looks to curb obesity

A Q&A with ReShape Medical CEO Richard Thompson on the company's cash pay procedure and how it can make a dent in obese patients.

DeviceTalks podcast: Masimo CEO Kiani

An interview with medtech entrepreneur Joe Kiani, CEO of Masimo Corp. and the founder of the Patient Safety Movement Foundation, recorded at DeviceTalks West Nov. 19, 2014.

HeartFlow wins FDA OK for non-invasive FFR system

The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.

DeviceTalks podcast: B. Braun Medical CEO Caroll Neubauer on device tax, Obamaca

Caroll Neubauer, the CEO of B. Braun Medical, sits down for a wide-ranging interview on the hottest topics facing the medical device industry.

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The objective of this analysis was to assess whether timelines associated with the De Novo Process are in line with FDA’s stated goals.    
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FDA asks dermal filler makers to indicate risk of serious injury

May 28, 2015 by MassDevice

The FDA wants companies that make dermal fillers to treat wrinkles to update their labeling to indicate the risk of injury from unintentional injection into blood vessels.

FDA asks dermal filler makers to indicate risk of serious injury

(Reuters) — The FDA today asked manufacturers of dermal fillers to update their labeling to reflect the possible risk of serious injuries caused by unintentional injection of the fillers into the blood vessels in the face.

Report: Boston Scientific loses $100m pelvic mesh case

May 28, 2015 by Brad Perriello

A Delaware state jury reportedly slaps Boston Scientific with a $100 million judgment in a pelvic mesh lawsuit, the largest verdict so far against the medical device giant.

Report: Boston Scientific loses $100m pelvic mesh case

FDA down-classifies Ergon Medical's Prolong PE device

May 28, 2015 by Fink Densford

The FDA down-classifies Ergon Medical's Prolong premature ejaculation treatment from Class III to Class II.

FDA Reclassifies Prolong premature ejaculation vibrator

The FDA said it down-classified the Prolong device, a vibrator used to treat premature ejaculation, from Class III to Class II after a request from Ergon Medical Ltd., creator of the device.

Ventripoint wins expanded FDA indication, seeks $700k

May 28, 2015 by Fink Densford

Ventripoint says won an expanded indication from the FDA for its VMS cardiac diagnostic device and is seeking to land a $700,000 private placement.

Ventripoint wins expanded FDA indication, seeks $700k

Si-Bone raises $21m, appoints new CFO

May 28, 2015 by Fink Densford

Si-Bone says it raised a $21 million funding round and appointed Laura Francis as its new CFO.

Si-Bone raises $21m, appoints new CFO

Si-Bone said yesterday that the medical device company raised a $21 million funding round and hired Laura Francis as its new CFO.

J&J accepts binding offer from Cardinal Health for Cordis unit

May 28, 2015 by Brad Perriello

Johnson & Johnson accepts a binding, $2 billion offer from Cardinal Health for its Cordis business.

J&J accepts binding offer from Cardinal Health for Cordis unit

Ex-accountant sues SpineFrontier

May 28, 2015 by Brad Perriello

A former accountant for SpineFrontier sues the orthopedic company for wrongful termination, alleging she was fired for raising concerns about regulatory issues that eventually led to an FDA warning letter.

Ex-accountant sues SpineFrontier

A former accountant for SpineFrontier sued the company this month for wrongful termination, alleging that the spinal implant maker fired her for raising concerns about manufacturing processes later flagged by the FDA in a warning letter.

China jacks up registration fees for medical devices, drugs

May 28, 2015 by MassDevice

The China Food & Drug Administration jacks up its registration fees for medical devices and drugs to help it cope with a rising backlog of applications.

China jacks up registration fees for medical devices, drugs

(Reuters) — The China Food & Drug Administration steeply raised the fees required to register medical devices and drugs in the world's 2nd-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.