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Olympus sold 'superbug' scopes without FDA clearance | Regulatory news for the week of March 9, 2015

March 10, 2015 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Olympus sold 'superbug' scopes without our clearance; FDA clears 1 Hospira plant, flags another; GI Dynamics plunges 50% after FDA halts trial; Sunshine Heart stops trial enrollment after patient deaths; Petition accuses Bayer's Conceptus of altering Essure trial data

FDA: Olympus sold 'superbug' scopes without our clearance

March 5, 2015 by Brad Perriello

Petition accuses Bayer's Conceptus of altering Essure trial data

March 9, 2015 by Brad Perriello

A citizens petition filed last month with the FDA accuses Bayer subsidiary Conceptus of altering the clinical trial data for its Essure female sterilization device to win pre-market approval from the safety watchdog.

Petition accuses Bayer's Conceptus of altering Essure trial data

UPDATED March 10, 2015, with comment from Bayer.

Exclusive: Bionics maker BiOM taps Charles Carignan for CEO role

July 7, 2014 by Brian Johnson

Dr. Charles Carignan, the former CEO of Ninepoint Medical, joins BiOM as its next CEO.

Exclusive: Bionics maker BiOM taps Charles Carignan for CEO role

BiOM has named Dr. Charles Carignan as its next CEO, replacing Tim McCarthy, who left the company this past spring.

Carignan is a 20-year medtech veteran who has held several key positions in the medical device industry, including most recently at NinePoint Medical, where he was the founder and CEO.

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Anti-Essure movement grows online as women slam Bayer's implant | MassDevice.com On Call

November 13, 2013 by Arezu Sarvestani

Women rallying against the Essure contraceptive implant are congregating online and picketing on street corners, calling on Bayer to recall the device.

MassDevice On Call

MASSDEVICE ON CALL — The anti-Essure movement, launched by women who claim the permanent contraceptive implant left them with severe pain and injuries, doesn't look likely to die down, having spawned Facebook support pages, Twitter campaigns and lots of media attention.

The movement has attached itself to the Twitter hashtag '#EssureRally', through which women are calling on Bayer to recall the device, posting pictures of the ralliers in action and organizing real-world events, including street-corner picketing and conference calls with famed consumer advocate Erin Brockovich.

Medtech analyst chides Erin Brockovich's crusade against Bayer's birth control implant

November 7, 2013 by Arezu Sarvestani

GlobalData analyst Joseph Gregory says public advocate Erin Brockovich's patient safety claims against Bayer's Essure contraceptive implant are "inappropriate" and "unsubstantiated."

Analysts chide Erin Brockovich's crusade against Bayer's birth control implant

FDA responds to patient uprising over Bayer's Essure birth control implant

October 21, 2013 by Arezu Sarvestani

The FDA says its additional review suggests Bayer's Essure permanent birth control device isn't connected to rising patient reports of post-treatment weight-gain, depression and fatigue.

FDA responds to patient uprising over Bayer's Essure birth control implant

It looks like healthcare giant Bayer (PINK:BAYRY) has got the FDA in its corner against a rising tide of patient complaints over the company's Essure permanent birth control device.

The real Erin Brockovich takes on Bayer's birth control | MassDevice.com On Call

October 17, 2013 by Arezu Sarvestani

Real-world consumer advocate Erin Brockovich sets her sights on healthcare giant Bayer's Essure contraceptive implants.

MassDevice On Call

MASSDEVICE ON CALL — Erin Brockovich, the activist made famous by Julia Roberts' portrayal in a 2000 blockbuster film, is taking on healthcare giant Bayer (PINK:BAYRY), saying the company's Essure birth control device has harmed women.

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