Tag: BMC Medical
FDA sends warning to BMC Medical for allegedly adulterating, misbranding device
July 14, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices, which are imported into the United States by React Health (formerly 3B Medical). Through an inspection, the agency determined that BMC made significant design and software changes to a previously cleared Luna APAP device without submitting a new 510(k) premarket notification for FDA review. The newly branded G3X APAP, the...
In brief: Apnimed files for IPO, BMC receives warning, Quality Biomed makes buy
July 10, 2026HME News Staff
CAMBRIDGE, Mass. – Apnimed has filed for an initial public offering (IPO) and announced the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application filing for Oxnimbi, an oral treatment for obstructive sleep apnea (OSA).
In its Form S-1, the company acknowledges positive airway pressure (PAP) as the current standard of care for OSA, but notes many patients refuse or discontinue the treatment due to issues such as discomfort, pressure intolerance and...
ResMed settles with 3B Medical
February 3, 2017Liz Beaulieu, Editor
SAN DIEGO - ResMed recognized an expense of $8.5 million in its second quarter fiscal year financial results, part of a global settlement of all litigation between the company and BMC and its U.S. distributor 3B Medical.
ResMed and 3B Medical announced a five-year settlement on Jan. 21 that involves ResMed making a one-time payment to 3B Medical to close ongoing litigation between the two companies in Florida.
“Obviously, one of the reasons you settle cases is to avoid the further ongoing...
3B Medical links up with Vodafone
February 18, 2016HME News Staff
WINTER HAVEN, Fla. - 3B Medical and BMC Medical have chosen Vodafone to deliver sleep data and compliance information wirelessly. The deal will allow patients using 3B Medical Luna devices who are traveling abroad or who don't have Wi-Fi connections in their home to automatically upload sleep data in real-time to 3B's cloud-based patient management system, iCodeConnect. “The addition of mobile data significantly enhances our wireless functionality with a device that automatically uploads to...
BMC wins action against ResMed
February 9, 2016HME News Staff
BEJING - BMC Medical has won a global patent infringement litigation action against ResMed, it has announced. The U.S. Patent and Trademark Office issued a series of judgments in connection with inter partes review of U.S. Patent No. RE44453 on Jan. 21, 2016, and found 32 claims invalid, the company says. “We have now built a powerful patent team to support our strong resources in research and development,” stated Denny Wu, BMC's head of intellectual property department. “In less...
In brief: CMS rethinks miscellaneous codes, House votes to repeal medical device tax
June 26, 2015HME News Staff
WASHINGTON - CMS is proposing new codes for miscellaneous DME to reflect more accurate payment of Medicare claims.HCPCS codes E1399 and K0108 are currently used to bill for inexpensive items; however, the agency proposes to replace them with new codes effective Jan. 1, 2016.The public is invited to submit electronic comments on the proposal until July 9, 2015.The proposed codes are:KXXX1: Durable medical equipment, miscellaneous, the purchase price does not exceed $150. Based on the average reasonable...
BMC Medical wins case
June 25, 2015HME News Staff
BEIJING - BMC Medical has announced that it has won an overseas patent infringement case against ResMed. ResMed previously filed a preliminary injunction against the Chinese manufacturer for a CPAP respiratory system machine with a detachable water talk. During an Oct. 23, 2014, hearing, the Court of Munich I lifted the preliminary injunction against BMC Medical “based on the considerably uncertain patentability of ResMed's patent.” ResMed filed an appeal, but the decision was upheld.
German court upholds injunction in ResMed vs. BMC
February 13, 2015HME News Staff
SAN DIEGO - ResMed announced Feb. 12 that the Munich District Court has upheld an injunction against Chinese medical device manufacturer BMC Medical. The injunction prohibits BMC from offering, selling or distributing infringing mask products in Germany. The court has upheld an injunction first rendered in November 2013 that respiratory mask assemblies, such as BMC's Willing and FeaLite nasal pillow masks, infringe ResMed's European patent EP 1356842. BMC will not be allowed to sell infringing...
BMC takes patent fight global
July 29, 2014HME News Staff
LAKE WALES, Fla. - BMC Medical and 3B Medical announced today that they have now filed challenges to ResMed patents in China, Germany and the United States. The move represents a “global strategy to go on (the) offense and seek to invalidate portions of ResMed's patent portfolio” in all three countries, the company stated in a release. “We have to be proactive on the global landscape to assert our right to compete in this product space,” stated James Xu, president of BMC Medical,...
Gov't agrees to re-examine ResMed patents
February 26, 2014HME News Staff
SAN DIEGO - The U.S. Patent and Trademark Office has agreed to re-examine five ResMed patents in response to challenges filed by Apex Medical, the manufacturer has announced. Apex had filed challenges against ResMed in August 2013 for six patents related to CPAP machines and masks. It's the latest move in an ongoing patent battle between ResMed and Apex. On Feb. 19, Apex filed challenges to four patents in European and German patent offices. In November, ResMed won preliminary injunctions in Germany...