Medical Devices News and Research

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FDA probes malfunctions of medical devices made by man who has championed patient safety

A Food and Drug Administration investigation last year found that Masimo Corp. did not adequately look into reports of problems with its devices, ProPublica reports, even though the company owner, Joe Kiani, has created a foundation dedicated to eliminating medical mistakes. In addition, the Boston Globe examines how medical technology companies are looking for new strategies to boost sales.

8 Oct 2014

Kalorama Information: Global patient monitoring market worth $29.7 billion

The global advanced patient monitoring market is currently worth about $29.7 billion, up 7% from last year, according to Kalorama Information.

7 Oct 2014

Absorption Systems supports Pediatric Praziquantel Consortium led by Merck KGaA

Absorption Systems, a leader in preclinical contract testing of drugs, biologics, and medical devices, announces that it has been subcontracted by the German pharmaceutical company Merck KGaA to work on a new pediatric formulation of praziquantel.

7 Oct 2014

Another shortfall in the doctor payment database revealed

Federal officials report that the Open Payments database, which seeks to make drug and medical device company payments to doctors and hospitals available to consumers, is missing $1.1 billion in payments made between August and December 2013.

7 Oct 2014

Pinnacle initiates pivotal Phase 3 trial in Germany for rare form of bile duct cancer

Pinnacle Biologics, Inc., a subsidiary of Concordia Healthcare Corp., announced today the initiation of the pivotal Phase 3 trial (OPUS) in Germany for a rare form of bile duct cancer for which there is currently no acceptable therapy.

7 Oct 2014

Cognizant announces acquisition of Cadient Group

Cognizant today announced it has acquired Cadient Group, a full-service digital marketing agency that serves a broad spectrum of life sciences companies in the pharmaceutical, biotechnology, consumer health, and medical device industries.

7 Oct 2014

Viewpoints: Health costs and income inequality; vital matters when approaching life's end

Government data show that health costs are the biggest driver of income inequality in America today. Most employers pay workers a combination of wages and benefits, the most important of which is health coverage. Economic theory says that when employers' costs for benefits like health coverage rise, they will hold back on salary increases to keep total compensation costs in check. That's exactly what seems to have happened: Bureau of Labor Statistics data show that from June 2004 to June 2014 compensation increased by 28 percent while employer health-insurance costs rose by 51 percent. Consequently, average wages grew by just 24 percent (Mark J. Warshawsky and Andrew G. Biggs, 10/6).

7 Oct 2014

Financial ties between doctors and health firms explored

Federal data shows that doctors and other health care professionals made more than $212 million in speaking and consulting for drug and device makers in the five months at the end of last year, reports The New York Times.

3 Oct 2014

Viewpoints: Another troubled website rollout; insurers fight consumer measures in Calif.

If the federal government's new Open Payments website were a consumer product, it would be returned to the manufacturer for a full refund. Open Payments is the government's site for publishing payments made to doctors and teaching hospitals by drug and medical device manufacturers. It includes 4.4 million payments, worth $3.5 billion, to more than half a million doctors and almost 1,360 teaching hospitals (Charles Ornstein, 10/1).

3 Oct 2014

Early review: Open payments database not so open

The new federal website, which was created to provide information about financial links between physicians and the drug industry, is not user-friendly, notes The Associated Press. Meanwhile, The Wall Street Journal digs into the data to see what it shows about the ties between medical professionals and the drug industry.

3 Oct 2014

Open payments database debuts, detailing financial connections between physicians and drug makers

Consumer advocates have pushed for years for this kind of government database in an effort to protect against physicians' conflicts of interest, to safeguard patient care and to prevent unnecessary costs to public health programs.

1 Oct 2014

Viewpoints: Shop around for health coverage; 'gaming' Obamacare; FDA and painkillers

My colleagues Margot Sanger-Katz and Amanda Cox wrote recently that shopping around for the best price can be crucial for people renewing their coverage on the health insurance exchanges this fall.

1 Oct 2014

Endo resolves claims relating to vaginal mesh products

Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced that it has reached master settlement agreements with several of the remaining leading plaintiffs' law firms to resolve claims relating to vaginal mesh products sold by Endo's AMS subsidiary.

1 Oct 2014

Drug and device news: Study questions medical devices' safety evidence

Elsewhere, The Associated Press reports on a new advertising approach for Viagra -- a TV commercial that targets women.

1 Oct 2014

Website launches today showing drugmakers' payments to doctors

The so-called Open Payments program is intended to shine a light on potential ethical conflicts and allow patients to look up their doctors online. The first batch of data, however, will be incomplete, covering only a few months at the end of 2013. Journalism website ProPublica says it has tracked 3.4 million payments to health professionals since 2009, totaling more than $4 billion.

30 Sep 2014

Acutus Medical concludes additional $26.2M financing round to broaden its product portfolio

Acutus Medical, Inc. (ACM), a medical device company developing a minimally invasive real-time 3D Cardiac Chamber Imaging and Dipole Density Mapping system to identify the sources that cause and / or sustain complex cardiac arrhythmias, including atrial fibrillation, announced it has completed an additional $26.2M financing to continue developing its imaging/mapping system as well as bring to market a complete product portfolio.

30 Sep 2014

Synapse Biomedical completes enrollment in post-approval study of NeuRx DPS for ALS patients

Synapse Biomedical Inc. announced today it has completed the enrollment of the post-approval study of its NeuRx DPS System for ALS patients.

30 Sep 2014

Moberg receives CE Mark approval for CNS Monitor

Moberg has received CE Mark approval for the CNS Monitor, a medical device used for advanced monitoring of neurological intensive care patients. The CE Mark certifies that a product has met European Union requirements for commercial marketing in Europe.

30 Sep 2014

Galmed Pharmaceuticals purchases EndoPAT devices, accessories from Itamar Medical

Galmed Pharmaceuticals Ltd. ("Galmed"), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral medication for the treatment of liver diseases and cholesterol gallstones, announced today that it purchased 60 EndoPAT™ devices and accessories from Itamar Medical Ltd.

29 Sep 2014

Cantel Medical achieves record revenue growth in fourth quarter 2014

CANTEL MEDICAL CORP. reported net income of $10,705,000, or $0.26 per diluted share, on a 15% increase in sales to a record $131,377,000 for the fourth quarter ended July 31, 2014, inclusive of $0.02 for charges related to acquisition and CFO retirement costs.

29 Sep 2014

Medical Devices News and Research

FDA probes malfunctions of medical devices made by man who has championed patient safety

Kalorama Information: Global patient monitoring market worth $29.7 billion

Absorption Systems supports Pediatric Praziquantel Consortium led by Merck KGaA

Another shortfall in the doctor payment database revealed

Pinnacle initiates pivotal Phase 3 trial in Germany for rare form of bile duct cancer

Cognizant announces acquisition of Cadient Group

Viewpoints: Health costs and income inequality; vital matters when approaching life's end

Financial ties between doctors and health firms explored

Viewpoints: Another troubled website rollout; insurers fight consumer measures in Calif.

Early review: Open payments database not so open

Open payments database debuts, detailing financial connections between physicians and drug makers

Viewpoints: Shop around for health coverage; 'gaming' Obamacare; FDA and painkillers

Endo resolves claims relating to vaginal mesh products

Drug and device news: Study questions medical devices' safety evidence

Website launches today showing drugmakers' payments to doctors

Acutus Medical concludes additional $26.2M financing round to broaden its product portfolio

Synapse Biomedical completes enrollment in post-approval study of NeuRx DPS for ALS patients

Moberg receives CE Mark approval for CNS Monitor

Galmed Pharmaceuticals purchases EndoPAT devices, accessories from Itamar Medical

Cantel Medical achieves record revenue growth in fourth quarter 2014

Industry Focus - Medical Device eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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