Biomedical Market Newsletter articles from April 2001

Biomedical Market Newsletter archives from April 2001

Patent Term Restoration, Due Diligence Petitions, Filing, Format & Content of Petitions.(Food and Drug Administration inviting commentary)(Brief Article)
April 30, 2001... Federal Register/Vol. 66, No. 57/March 23, 2001 [Docket No. 0IN-0114] SUMMARY: The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of...

New Hospital Closures Report Released By Inspector General.(Brief Article)
April 30, 2001... The findings of this year's DHHS Office of the Inspector General (OIG) report (released March 30, 2001) are consistent with those of all previous 13 years, they note. The hospitals that closed in 1999 were few in number and small in size. They...

FDA To Conduct Voluntary Survey of Single-Use Medical Device Reuse & Reprocessing in Hospitals.(Brief Article)
April 30, 2001... DEADLINE: Comments are due by June 29, 2001. US DHHS Food & Drug Administration 21399 Federal Register/Vol. 66, No. 83/April 30, 2001 [Docket No. 01N-01751 Agency Information Collection Activities; Proposed Collection; Comment Request;...

FDA Discusses Reuse of Single Use Devices: Policy Now Established.(Brief Article)
April 30, 2001... Outline of his April 23, 2001 presentation. WHY DEAL WITH THIS ISSUE? * Identical regulatory controls - Reprocessing IS manufacturing * Public concern * FDA research shows reprocessing may be feasible, but it is difficult and...

FDA Announces Data Collection Review of 510(k) Submissions Information.
April 30, 2001... DEADLINE: Comments are due by June 29, 2001. Proposed Collection; Comment Request; Premarket Notification 510(k) Submissions AGENCY: DHHS Food & Drug Administration ACTION: Notice. 21398 Federal Register/Vol. 66, No. 83/April 30,...

US Endoscopy Market : Endoscope Manufacturers Employ Novel Strategies in Race for Profitability.
April 30, 2001... Endoscopes are increasingly involved in performing some of the most common surgical procedures, as well as diagnosing cancer and other conditions. Companies are focusing on increasing their endoscopes' durability, narrowing its diameter and...

EXHIBIT 1 : ALL FDA 510(K) APPROVALS FOR ALL ENDOSCOPES, ARRANGED BY DATE (NEWEST APPROVED ARE 1ST), 1976 THROUGH APRIL 30, 2001.
April 30, 2001... EDITOR'S NOTE: The following FDA data was compiled by Biomedical Market Newsletter, exclusively for our subscribers, and is not part of the Frost & Sullivan study. Some company names have changed while other firms have been merged, acquired, or...

EXHIBIT 2 : ALL FDA 510(K) APPROVALS FOR ANY TYPES OF SCOPES, ARRANGED BY DATE (NEWEST APPROVED ARE 1ST), SEPT. 1994 THROUGH APRIL 30, 2001.(Brief Article)
April 30, 2001... EDITOR'S NOTE: The following FDA data was compiled by Biomedical Market Newsletter, exclusively for our subscribers, and is not part of the Frost & Sullivan study. Some company names have changed while other firms have been merged, acquired, or...

OIG Insists On A Thorough Overhaul Of Medicare System.
April 30, 2001... Simply specifiying time limits for review will not correct the underlying problems, says OIG March 15, 2001 Testimony Before the House Committee on Ways & Means Subcomittee on Health Good morning, Madam Chairman. I want to thank you...

HIPAA, HCFA & Medicare Fraud: Improvements Have Been Made But It Is Still Not Enough.
April 30, 2001... April 4, 2001 Testimony Before the House Energy &Commerce Subcommittees on Health, Oversight & Investigations Health Care Financing Administration's Communication with Medicare Providers & Contractors Good morning Mr. Chairman and...