FDA delays approval of MDF medical instruments

FDA delayed the approval of medical devices for use in the emergency department for more than a year because the devices have no standard operating procedures and are not required to be properly designed, according to a new report.

A team of researchers from Stanford University and the University of Minnesota reviewed more than 500,000 patient-reported reports from the National Health and Medical Research Council (NHMRC) of the U.S. Department of Health and Human Services and concluded that the devices are “unsuitable for emergency use,” the New York Times reported.

The researchers concluded that “the devices have insufficient safety features to ensure safe use,” according to the report.

The FDA’s Office of Medical Devices is required to approve medical devices under certain circumstances, but this is not one of them, according a spokesperson for the agency.

The device makers involved are in the process of developing standards for their products and “have not submitted their final design for review,” the spokesperson told the Times.

The makers of the devices “are actively working to develop standard operating procedure (SOP) specifications for these devices, and are in discussions with regulators about this,” according the spokesperson.

The report was published on Sunday, and the agency is expected to issue a final rule in the coming months.

MDF Medical Instruments sells $3bn to Ireland – Irish Times

The Medical Instruments Group (MIF), which owns and operates some of the world’s largest medical equipment companies, has sold $3.5bn of its shareholding in the medical device maker Biostar to Ireland’s Anglo Irish Bank.MIF will retain a majority interest in the company, which has about 70 per cent of its market share in the US.

Biostar, based in Mountain View, California, said it had “a very positive, positive outlook for its future and a strong cash position” after receiving the investment.

Its share price has increased by over 10 per cent in recent weeks and now trades at about $8.70, about $100 more than its IPO price.

The deal was announced in a letter sent by Biostars chief executive John Boulton and senior vice president of finance Richard Pignatelli.

It comes after the company announced it had raised $5.2bn in funding from venture capital firms Andreessen Horowitz, Union Square Ventures, Kleiner Perkins Caufield & Byers and others.

Mif also said it would remain an investment vehicle for Biostara, as part of its strategy to become a diversified, global, sustainable technology company.

The news was greeted with optimism by some analysts.

The Irish stock market was the world leader for the first time last year, with a rally of 6 per cent, or $7.70.

In its letter, Boulson said that the combination of the two companies will allow Biostark to become an attractive investment vehicle in the future.

“We look forward to continuing to support our Biostarr brand through a diversification of investments that will deliver long-term value and growth,” he wrote.

The company has been heavily criticised by its customers, including a group of doctors who say that BiostAR’s prices have become too high.

The medical device makers have also been criticised for not providing enough information about its products.