HHS renews COVID-19 public health emergency

The extension supported by AdvaMed, the American Clinical Laboratory Association and American Hospital Association takes effect Saturday and opens the door for FDA to keep issuing emergency use authorizations.

By Shannon Muchmore • July 23, 2020

Medical device deal values down 88% amid COVID-19 disruption: PwC

Going forward, M&A may rise in light of recent deferral of elective procedures, which analysts say “could create the need for significant consolidation as companies work to remain competitive.”  

By Nick Paul Taylor • July 23, 2020

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Boston Scientific to begin limited US launch of latest Watchman device

The medtech hopes the updated version of its high-growth stroke technology will help boost its interventional cardiology unit as elective procedures pick back up.

By Maria Rachal • July 22, 2020

Intuitive plans to lower instrument prices as it warns of long recovery

The surgical robots maker reported a pullback in revenue and earnings as it weathers the one-two COVID-19 punch of delayed elective procedures and constrained capital equipment spending.

By Susan Kelly • July 22, 2020

AdvaMed launches COVID-19 test registry to address shortages

Created in partnership with Abbott, Roche, Siemens and others, the database is aimed at helping ensure sufficient testing supply by providing weekly state- and national-level updates on the number of tests shipped.

By Nick Paul Taylor • July 22, 2020

NuVasive surprises analysts with sooner-than-expected spine surgery sales rebound

Preliminary second quarter results show sales were down 30% year over year but were about a third higher than average analyst expectations, adding to evidence of a faster-than-predicted COVID-19 recovery in the medtech sector.

By Nick Paul Taylor • July 21, 2020

As pandemic rages on, hip and knee surgeons lay out elective procedure guidance

An international group of orthopaedic experts outlined recommended changes to hospital protocols to prevent transmission of COVID-19 when elective procedures resume.

By Susan Kelly • July 20, 2020

Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip

Headwinds won out this spring, dragging total sales down 6%. Still, management predicted the return of elective procedures will help tip the balance to growth for the rest of the year.

By Nick Paul Taylor • July 20, 2020

Ambu wins FDA clearance for single-use duodenoscope product

Boston Scientific was first to obtain an agency nod for a fully disposable version, meant to be safer against infection, which it believes could be worth more than $1 billion.

By Maria Rachal • July 17, 2020

J&J drops planned 510(k) for Verb-Auris robot, targets 2022 clinical trial start

Talks with the FDA led Johnson & Johnson to opt against trying to bring its general surgery robotics platform to market via the 510(k) pathway. Launch delays buy market incumbent Intuitive some important time, analysts noted.

By Nick Paul Taylor • July 17, 2020

J&J device sales fell by one-third in Q2, but June rebound drives better 2020 outlook

Device sales in some areas returned to around 90% of pre-pandemic levels by the end of the quarter, causing J&J to improve its 2020 worst-case scenario for the division by $1.75 billion.

By Nick Paul Taylor • July 16, 2020

Abbott tops Q2 estimates aided by 233.6% jump in molecular diagnostics

The medtech giant reported $7.3 billion in second quarter revenue, including $615 million from coronavirus testing products. Molecular diagnostics sales were driven by strong demand for its point-of-care ID NOW platform.

By Greg Slabodkin • July 16, 2020

Medtronic closes Medicrea buyout, seeking spinal surgery boost

Four months after announcing the deal for the French medtech, Medtronic also highlighted its expanding foothold in AI, machine learning and predictive analytics. 

By Maria Rachal • Updated Nov. 16, 2020

UK signals Stryker offer to unload ankle replacement product could clear Wright Medical buy

The medtech giant's proposed $4 billion acquisition prompted competition concerns among regulators. Stryker disclosed in a filing Wednesday it pitched divesting its STAR product line, which may satisfy U.K. authorities.

By Greg Slabodkin • July 15, 2020

FDA commits to staggered move to electronic medtech filings

Finalized guidance on electronic submissions of medical device regulatory filings takes into account AdvaMed comments on timing.  

By Nick Paul Taylor • July 15, 2020

Smith & Nephew launches new hand-held robotic tool amid COVID-19 health sector pullback

The London-based medtech is betting portability and potentially faster knee procedure times will attract customers despite a slowdown in capital equipment orders and drop in elective surgeries during the pandemic.

By Susan Kelly • July 15, 2020

ElectroCore noninvasive nerve stimulator gets EUA for COVID-19 patients with asthma

The small medtech has focused on migraine and cluster headache, but FDA's support could be a first step to developing evidence to back expansion of noninvasive vagus nerve stimulation into reactive airway disease.

By Susan Kelly • July 14, 2020

FDA proposes BPH device trial guidance changes as market heats up

The updates come as a swath of companies take aim at the benign prostatic hyperplasia opportunity, which medtechs like Boston Scientific and Teleflex have invested in more since FDA issued development guidance a decade ago.

By Nick Paul Taylor • July 14, 2020

Edwards to pay Abbott $468M to settle mitral, tricuspid repair device patent disputes

Jefferies analysts called the settlement "a very good deal" for Edwards as it opens up a market opportunity that may be worth $3 billion come 2024.

By Nick Paul Taylor • July 14, 2020

An insider's look at how GM, Ventec ramped up ventilator production amid COVID-19

The weight of the Defense Production Act was key in opening doors, said the CEO of the engineering firm contracted to test each of the 30,000 devices expected under the agreement.

By Greg Slabodkin • July 13, 2020

Abbott lays out plan for US study of FreeStyle Libre 3

The sign of potential progress on the medtech's next version of its glucose monitoring technology comes about a month after Libre 2 gained FDA's green light, albeit without the OK to integrate with automated insulin delivery systems.

By Maria Rachal • July 13, 2020

FDA plans to restart domestic inspections, contingent on local coronavirus trends

The agency is aiming to resume some on-site surveillance the week of July 20 after shutting down non-critical inspections in March due to the COVID-19 outbreak.

By Maria Rachal • July 10, 2020

Intersect ENT stock jumps on report of potential Medtronic takeover

A Bloomberg report published late Tuesday said the medtech giant had made an offer for the sinusitis tech maker, citing people with knowledge of the matter. Shares in Intersect were up around 35% early Wednesday.

By Maria Rachal • July 8, 2020

CMS not yet sold on Baxter, Outset tech in kidney care payment proposal

The agency said the need for more at-home care has never been more urgent, as the end-stage renal disease population has the highest rate of hospitalization due to COVID-19 among Medicare beneficiaries.

By Samantha Liss , Maria Rachal • July 8, 2020

Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate

The U.S. marketing clearance comes on the heels of an FDA nod for Boston Scientific's LUX-Dx insertable cardiac monitor, which also can be programmed remotely by a physician.

By Susan Kelly • July 8, 2020