Philips has agreed to pay an undisclosed amount for St. Paul, Minn.-based Respiratory Technologies, which manufactures the inCourage line of inflatable, pulsating airway-clearance vests for treating patients with chronic respiratory conditions. RespirTech, with revenue closing in on $50 million this year, will maintain its executive team, as well as its operations in the Twin Cities.
Want to sell your medical device in Japan? Here's how to get started Japan's medical device registration process can be intimidating for foreign manufacturers, primarily because most published compliance information is in Japanese! In this paper, Emergo's team in Japan outlines the entire registration process, explaining how devices are classified, the role of JMDN codes, complying with QMS ordinance #169, appointing a DMAH and finally submitting a registration dossier. DOWNLOAD THE WHITE PAPER NOW.
Canton, Mass.-based advanced wound care innovation and technologies developer Organogenesis has secured a financing facility worth $20 million from Eastward Capital Partners. The money will be used for the continued enhancement of the company's product portfolio.
Finesse Medical, an Irish company that makes products for wound care, has been acquired by US-based Avery Dennison for undisclosed terms. Finesse Medical, which made approximately $16.8 million in revenue last year, is expected to complement Avery Dennison's Vancive Medical Technologies subsidiary.
Singapore-based QT Vascular has announced that it is in talks with interested third parties to seek out potential deals for its coronary products. The company said potential transactions will not involve or be in conflict with the Chocolate PTA nondrug-coated balloon, on which Medtronic has already agreed to pay $28 million for an option.
Rosetta Genomics has announced plans for a potential sale of its PersonalizeDx business, which markets fluorescence in situ hybridization-based cancer tests as part of its corporate strategy realignment to concentrate on the RosettaGx Reveal microRNA-based thyroid nodule classification assay. The sale "would have the benefit of bringing in nondilutive cash, as well as reducing our cash burn rate by approximately 20 percent," said company President and CEO Kenneth Berlin.
A Meddevicetracker report predicts the global sales of spinal cord stimulation systems will reach $2.4 billion by 2021 with a 6% compound annual growth rate. The largest market growth will continue to come from the dominant market, the US, because of the increasing demand for pain-management solutions from an expanding aging and obese population, more regulatory approvals of SCS products and an increasing interest in the use of the devices as an alternative treatment.
AdvaMed has launched a new value initiative that includes extensive tables of questions to help medical device companies formulate value-based arguments. "Value" has become an important word in medtech in recent years as government and private health care payers in the US and around the world have moved toward supporting more efficient and effective care. To help its members better navigate this new world, AdvaMed brought in Deloitte Consulting to produce a framework so that device companies can come up with truly comprehensive value-based arguments. Read the story.
A 181-site randomized, controlled trial published in the European Heart Journal showed positive results for Biotronik's home monitoring system, which enables wireless transmission of cardiac data to Biotronik servers to connect patients to providers. Use of the system in over 2,400 patients led to a 36% reduction in all-cause mortality and hospitalizations.
The FDA granted New York-based Soterix Medical 510(k) clearance for its IontoDC system, a device intended for introducing ions of soluble salts and drugs into the body using 10, 20, 30 or 40 minutes of direct current. The system, which comes with automatic ramp up and down and resistance meters, provides direct current with intensities ranging from 1 to 2 mA.
Australia's Therapeutic Goods Administration has proposed the use of overseas marketing approval of medical devices to support inclusion in the Australian Register of Therapeutic Goods or the sharing of such work with comparable overseas regulators to advance parallel submissions. Under the proposal, which is open for comments until June 30, the Australian regulator would only evaluate International Medical Device Regulators Forum members but would also use application-by-application assessment for work-sharing agreements.
A recall initiated by Royal Philips' Respironics business involving 20,690 units of its V60 noninvasive ventilator has been classified by the FDA as Class I. The recall was issued over concerns about the risk of serious adverse health consequences that could happen if the ventilation unexpectedly shut down because of a loose pin within the internal cable connecting the motor to the control board.
June 6-7 | Golden Valley, Minn. Maintaining effective design control procedures is a key element of the quality system regulation. This interactive workshop takes attendees step by step through all aspects of design control, emphasizing how it interacts with other quality system elements and other company functions. Learn more.
The AdvaMed Purchasing Group is a new member-only benefit that helps companies purchase the very best goods and services from nationally recognized suppliers at the very best cost, using a trusted and proven vetting system and the collective purchasing power of our membership. Participation is free for AdvaMed members, and there are no minimum commitments. Get started today.