Content about Medical device

January 22, 2013
J&J introduces innovation to diabetes diagnostics and insulin delivery space

During its annual business review Tuesday, Johnson & Johnson announced that the recent introduction of the OneTouch Verio Glucose testing platform represented one of the first diabetes care devices to alert and display high/low patterns that deliver more meaningful and actionable insights to help patients better understand and manage their diabetes.

NEW YORK — During its annual business review Tuesday, Johnson & Johnson announced that the recent introduction of the OneTouch Verio Glucose testing platform represented one of the first diabetes care devices to alert and display high/low patterns that deliver more meaningful and actionable insights to help patients better understand and manage their diabetes.

May 31, 2012
House passes PDUFA bill 387 to 5

The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

WASHINGTON — The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

The bill, a version of which already passed through the Senate, now heads to committee where the House and Senate versions of the bill can be reconciled before Oct. 1 and submitted to the president. According to published reports, the Senate version would require more scrutiny for some new devices.

January 25, 2012
PMD launches first personal spirometer

Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.

ALLENTOWN, Pa. — Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.

PMD, based in Allentown, Pa., announced the launch of the Spiro PD, which recently received approval from the Food and Drug Administration. The device is designed to enable patients with such lung diseases as asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung transplants "easily and accurately" monitor lung function anytime and anywhere.

December 15, 2011
Report: Making medical technology consumer-friendly will drive wellness market

Cambridge Consultants on Thursday released a report outlining how the health-and-wellness market may take shape as more consumer-friendly medical devices featuring the latest in technology reach the market.

CAMBRIDGE, Mass. — Cambridge Consultants on Thursday released a report outlining how the health-and-wellness market may take shape as more consumer-friendly medical devices featuring the latest in technology reach the market.

“Disruption in this market will come from medical firms moving from 10-year product lifecycles and confronting the 18-month lifecycles of the consumer world, and from consumer companies adapting to the rigorous processes demanded by medical regulations,” stated Duncan Smith, head of product development at Cambridge Consultants.

October 19, 2011
Abbott to split into two public cos. — medical devices and pharmaceuticals

Abbott on Wednesday morning announced plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals.

ABBOTT PARK, Ill. — Abbott on Wednesday morning announced plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals.

"Today's news is a significant event for Abbott, and reflects another dynamic change in our company's 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns," Abbott chairman and CEO Miles White said.

June 14, 2011
FDA bars H&P Industries, Triad Group from manufacturing, distributing OTC products

ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.

April 11, 2011
Endo to acquire American Medical Systems

Endo Pharmaceuticals will buy American Medical Systems for $2.9 billion, the drug maker said Monday.

CHADDS FORD, Pa. — Endo Pharmaceuticals will buy American Medical Systems for $2.9 billion, the drug maker said Monday.

Endo said it and AMS had reached an agreement whereby Endo would acquire the maker of devices and therapies for pelvic health for $30 per share. AMS’ business focuses on men’s health, women’s health and benign prostatic hyperplasia.

February 16, 2011
Lansinoh to control manufacturing assets for three of its products

Lansinoh Labs on Tuesday announced the acquisition of certain operational and manufacturing assets from En-Ko Electronic Control Systems in Izmir, Turkey. The acquisition will allow Lansinoh to directly control the manufacturing of the Lansinoh Affinity double electric breast pump, Lansinoh Affinity breast-milk storage bottles and Lansinoh ComfortFit flanges.

ALEXANDRIA, Va. — Lansinoh Labs on Tuesday announced the acquisition of certain operational and manufacturing assets from En-Ko Electronic Control Systems in Izmir, Turkey. The acquisition will allow Lansinoh to directly control the manufacturing of the Lansinoh Affinity double electric breast pump, Lansinoh Affinity breast-milk storage bottles and Lansinoh ComfortFit flanges.

The new company will operate as Lansinoh Laboratories Medical Device Design and join other Lansinoh company assets, including the Lansinoh and Momma brands.

November 30, 2010
PwC survey sheds light on public confidence, misconceptions about the FDA

The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

NEW YORK — The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

Approximately one-half of respondents reported they think the FDA does a good job, but more than one-third (36%) of U.S. consumers said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.

May 3, 2010
FDA asks Baxter Healthcare to recall, destroy volumetric infusion pumps

The Food and Drug Administration is ordering medical supply manufacturer Baxter Healthcare to recall and...