Some of the key activities of medical device players in the recent times included IPO filing, Fund raising, regulatory and others.
IPOs and Funding were among the fore- runners in the activity marathon of medical device players. IPO filing had a mix of both diagnostic and medical device sector. While some players seemed confident over their IPO call others were sceptical. Companies who remained the centre of IPO talks include Mainstay Medical, CardioDX, BBI Diagnostics. While some did cash in through public offering other relied on equity and debt financing gateways.GI dynamics required the cash to support development of its non surgical devices, while integrated diagnostics to push the marketing of its lung nodule tests.
While the money was being poured in the industry at one end a lot was getting out of it in the form of litigation payment. Vaginal mesh patient law suits remained the prominent issues in the majority of the court hearings. Situation went worse to a level that FDA intervened with switching the approval pathway for mesh from 510k to PMA.
Regulatory bodies also remained in talks, as they gave green flag for next generation of stents and pacemakers of BSC and Medtronic in Europe and Japan respectively.As few players tasted the success of product approval other tried to gather submission documents through clinical trial data, Medtronic remained ahead in the lane for its aortic heart valve clinical trial.
FDA –Medical Device OEM collaboration was not the only partnership that Industry got to witness there were others too, partnership such as Teleflex and Intuitive Surgical for Da Vinci device.